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Pharmaceuticals
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China Mycophenolate mofetil API Supplier,China Mycophenolate mofetil ManufacturerHits：1150
Time：2019-03-08 15:36:13 |
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| ITEM | STANDARD | RESULTS |
| Appearance | white or almost white crystalline powder | white crystalline powder |
| Solubility | Practically insoluble in water, freely soluble in acetone, sparingly soluble in anhydrous ethanol | Complies |
| IR | Complies | Complies |
| Melting point | About 96℃ | 97.3℃~98.8℃ |
| Appearance of solution | The solution is clear and colorless | Complies |
| Related substances | ||
| Total impurities | ≤0.70% | <0.70% |
| Impurity F | ≤0.50% | 0.12% |
| Impurity B | ≤0.20% | Absent |
| Impurity A,D,E,G,H | ≤0.10% | <0.10% |
| Any other impurity | ≤0.10% | <0.10% |
| Ethanol | ≤5000ppm | Absent |
| Butyl acetate | ≤5000ppm | 400ppm |
| Toluene | ≤890ppm | Absent |
| Sulphated ash | ≤0.10% | 0.04% |
| Loss on drying | ≤0.50% | 0.02% |
| Heavy Metal | ≤20ppm | Complies |
| Assay (on the dried basis) | 98%~102.0% | 99.70% |
| Conclusion | Meets the Requirements | |
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Email：ada@ipurechemical.com
